Glimepiride

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glimepiride (Rx) - Amaryl

 Class: Antidiabetics, Sulfonylureas

 Dosing & Uses


 Interactions
 Adverse Effects
 Warnings
 Pregnancy
 Pharmacology
 Images
 Patient Handout

Dosing & Uses


Adult

Dosing Forms & Strengths

tablet

 1mg
 2mg
 4mg

Type 2 Diabetes Mellitus

Initial: 1-2 mg PO qAM after breakfast or with first meal; may increase dose by 1-2 mg every
1-2 weeks; not to exceed 8 mg/day

Conversion from other oral hypoglycemic agents

 Observe patients carefully for 1-2 weeks when being converted from long half-life
sulfonylureas to glimepiride, because of potential for overlapping of hypoglycemic
effects

Dosing considerations

 Use in monotherapy or, if glycemic response to glimepiride is inadequate at


maximum dose, with insulin or metformin

Dosing Modifications
Renal impairment: 1 mg PO qDay; titrate dose based on fasting blood glucose levels

Hepatic impairment: Not studied; not recommended in severe impairment; initiate therapy
with 1 mg PO qDay and titrate carefully

PEDIATRIC

Safety and efficacy not established

GERIATRIC

Prolonged hypoglycemia reported with use; titrate dose conservatively; monitor for
hypoglycemic or hyperglycemic symptoms

Type 2 Diabetes Mellitus

1 mg PO qDay; titrate dose at weekly intervals to avoid hypoglycemia

Drug Interactions
Interaction Checker
glimepiride and

Type a dru

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Contraindicated (0)

Serious - Use Alternative (1)

 ethanol

ethanol, glimepiride. Other (see comment). High likelihood serious or life-threatening


interaction. Contraindicated unless benefits outweigh risks and no alternatives
available. Never use combination. Comment: Excessive EtOH consumption may alter
glycemic control. Some sulfonylureas may produce a disulfiram like rxn.

Significant - Monitor Closely (139)

 aceclofenac
 acemetacin
 albiglutide
 alogliptin
 aripiprazole
 asenapine
 aspirin
 aspirin rectal
 aspirin/citric acid/sodium bicarbonate
 atazanavir
 benazepril
 bexarotene
 bezafibrate
 bitter melon
 canagliflozin
 captopril
 celecoxib
 choline magnesium trisalicylate
 cinnamon
 ciprofibrate
 ciprofloxacin
 clarithromycin
 clotrimazole
 clozapine
 colesevelam
 dapagliflozin
 darunavir
 diclofenac
 diflunisal
 disopyramide
 elvitegravir/cobicistat/emtricitabine/tenofovir
 empagliflozin
 enalapril
 etodolac
 etoricoxib
 exenatide injectable solution
 exenatide injectable suspension
 fenbufen
 fenofibrate
 fenofibrate micronized
 fenofibric acid
 fenoprofen
 fleroxacin
 fluconazole
 fluoxetine
 flurbiprofen
 fosamprenavir
 fosinopril
 gemfibrozil
 gemifloxacin
 ibuprofen
 iloperidone
 imidapril
 indinavir
 indomethacin
 insulin aspart
 insulin aspart protamine/insulin aspart
 insulin detemir
 insulin glargine
 insulin glulisine
 insulin inhaled
 insulin isophane human/insulin regular human
 insulin lispro
 insulin lispro protamine/insulin lispro
 insulin nph
 insulin regular human
 isocarboxazid
 itraconazole
 ketoconazole
 ketoprofen
 ketorolac
 ketorolac intranasal
 ketotifen, ophthalmic
 levofloxacin
 linagliptin
 linezolid
 liraglutide
 lisinopril
 lopinavir
 lornoxicam
 lurasidone
 marijuana
 mecasermin
 mefenamic acid
 meloxicam
 metreleptin
 miconazole vaginal
 mipomersen
 moexipril
 moxifloxacin
 nabumetone
 nadolol
 naproxen
 nelfinavir
 norfloxacin
 ofloxacin
 olanzapine
 opuntia ficus indica
 oxaprozin
 paliperidone
 parecoxib
 peginterferon alfa 2b
 perindopril
 phenelzine
 pindolol
 piroxicam
 posaconazole
 probenecid
 propranolol
 quetiapine
 quinapril
 ramipril
 rifabutin
 rifampin
 rifapentine
 risperidone
 ritonavir
 salicylates (non-asa)
 salsalate
 saquinavir
 selegiline
 selegiline transdermal
 shark cartilage
 sulfadiazine
 sulfamethoxazole
 sulfamethoxypyridazine
 sulfasalazine
 sulfisoxazole
 sulindac
 timolol
 tipranavir
 tolfenamic acid
 tolmetin
 trandolapril
 tranylcypromine
 trimagnesium citrate anhydrous
 voriconazole
 xipamide
 ziprasidone

Minor (91)

 agrimony
 american ginseng
 aminolevulinic acid & methyl aminolevulinate
 amitriptyline
 amoxapine
 anamu
 aspirin
 aspirin rectal
 aspirin/citric acid/sodium bicarbonate
 balsalazide
 bendroflumethiazide
 budesonide
 chloramphenicol
 chlorothiazide
 chlorthalidone
 choline magnesium trisalicylate
 chromium
 clobetasone
 clomipramine
 clonidine
 cornsilk
 cortisone
 cyclopenthiazide
 cyclosporine
 damiana
 danazol
 deflazacort
 desipramine
 devil's claw
 dexamethasone
 diflunisal
 dosulepin
 doxepin
 dronabinol
 elderberry
 eucalyptus
 fludrocortisone
 fluoxymesterone
 fo-ti
 forskolin
 gotu kola
 guanabenz
 guanfacine
 gymnema
 horse chestnut seed
 hydrochlorothiazide
 hydrocortisone
 imipramine
 indapamide
 isoniazid
 juniper
 lofepramine
 lycopus
 maitake
 maprotiline
 mesalamine
 mesterolone
 methyclothiazide
 methylprednisolone
 methyltestosterone
 metolazone
 mianserin
 nettle
 nortriptyline
 ofloxacin
 orlistat
 oxandrolone
 oxymetholone
 pegvisomant
 potassium acid phosphate
 potassium chloride
 potassium citrate
 prednisolone
 prednisone
 protriptyline
 sage
 salicylates (non-asa)
 salsalate
 sitagliptin
 stevia
 sulfasalazine
 tacrolimus
 testosterone
 testosterone buccal system
 testosterone topical
 tongkat ali
 trazodone
 triamcinolone
 trimipramine
 vanadium
 willow bark

Adverse Effects
>10%

Hypoglycemia (4-20%)

1-10%

Dizziness (1.7%)

Asthenia (1.6%)

Headache (1.5%)

Nausea (1.1%)

<1%

Allergic skin reactions

Erythema

Morbilliform or maculopapular eruptions

Pruritus

Urticaria
Diarrhea

Gastrointestinal pain

Vomiting

Agranulocytosis

Anemia

Aplastic anemia

Leukopenia

Pancytopenia

Thrombocytopenia, hemolytic

Cholestasis

Elevation of liver enzyme levels

Hepatic porphyria reactions

Jaundice (rare)

Disulfiram-like reactions

Hyponatremia

Postmarketing Reports

Serious hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens- Johnson


Syndrome

Hemolytic anemia in patients with and without G6PD deficiency

Hepatic impairment (eg, cholestasis, jaundice), as well as hepatitis, which may progress to
liver failure

Porphyria cutanea tarda, photosensitivity reactions and allergic vasculitis

Leukopenia, agranulocytosis, aplastic anemia, and pancytopenia

Thrombocytopenia (including severe cases with platelet count <10,000/mcL) and


thrombocytopenic purpura

Hepatic porphyria reactions and disulfiram-like reactions


Hyponatremia and SIADH, most often in patients on other medications or have medical
conditions known to cause hyponatremia or increase release of antidiuretic hormone

Contraindications & Cautions


Contraindications

Hypersensitivity; sulfa allergy

Type 1 diabetes

Diabetic ketoacidosis (with or without coma)

Complicated gestational diabetes mellitus

Cautions

Patients with risk of severe hypoglycemia: Elderly, debilitated, or malnourished; adrenal or


pituitary insufficiency; patients with stress due to infection, fever, trauma, or surgery

If patient is exposed to stress, it may be necessary to discontinue glimepiride and initiate


insulin

Use caution in hepatic/renal impairment

Pregnancy, lactation

Increased risk of cardiovascular mortality

Persons allergic to other sulfonamide derivatives may develop allergic reaction to glimepiride

Hypoglycemia may be difficult to recognize in patients with autonomic neuropathy

Hemolytic anemia may occur with glucose 6-phosphate dehydrogenase (G6PD) deficiency
when treated with sulfonylurea agents

Pregnancy & Lactation


Pregnancy category: C

Lactation: Excretion in milk unknown; avoid

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal


risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or
animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies
not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive


evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives
exist.

NA:Information not available.

Pharmacology
Mechanism of Action

Initial effect to increase insulin secretion from beta cells; may also decrease rate of hepatic
glucose production and increase insulin receptor sensitivity

Absorption

Bioavailability: 100%

Initial effect: 1 hr

Peak plasma time: 2-3 hr

Max effect: 2-4 hr

Duration: 24 hr

Distribution

Vd: 8.8 L

Protein bound: 99.5%

Metabolism

Metabolized extensively by hepatic P450 enzyme CYP2C9 to less-active metabolites

Metabolites: Cyclohexyl hydroxy methyl derivative (M1; mildly active) and the carboxyl
derivative (M2; inactive)

Elimination

Half-life: 5-9 hr
Total body clearance: 47.8 mL/min

Excretion: Urine (60%); feces (40%)

Patient Handout
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62
Patient Education
glimepiride oral

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT
have all possible information about this product. This information does not assure that this
product is safe, effective, or appropriate for you. This information is not individual medical
advice and does not substitute for the advice of your health care professional. Always ask
your health care professional for complete information about this product and your specific
health needs.

GLIMEPIRIDE - ORAL

(glye-MEP-ir-ide)

COMMON BRAND NAME(S): Amaryl

USES:
Glimepiride is used with a proper diet and exercise program to control high blood sugar in
people with type 2 diabetes. It may also be used with other diabetes medications. Controlling
high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and
sexual function problems. Proper control of diabetes may also lessen your risk of a heart
attack or stroke. Glimepiride belongs to the class of drugs known as sulfonylureas. It lowers
blood sugar by causing the release of your body's natural insulin.

HOW TO USE:
Read the Patient Information Leaflet if available from your pharmacist before you start taking
glimepiride and each time you get a refill. If you have any questions, ask your doctor or
pharmacist.

Take this medication by mouth with breakfast or the first main meal of the day, as directed by
your doctor, usually once daily. The dosage is based on your medical condition and response
to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at
the same time each day.

To reduce your risk of side effects, your doctor may direct you to start this medication at a
low dose and gradually increase your dose. Follow your doctor's instructions carefully.
If you are already taking another anti-diabetic drug (such as chlorpropamide), follow your
doctor's directions carefully for stopping the old drug and starting glimepiride.

Colesevelam can decrease the absorption of glimepiride. If you are taking colesevelam, take
glimepiride at least 4 hours before taking colesevelam.

Tell your doctor if your condition does not improve or if it worsens (your blood sugar levels
are too high or too low).

SIDE EFFECTS:
Nausea and upset stomach may occur. If either of these effects persists or worsens, tell your
doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that
the benefit to you is greater than the risk of side effects. Many people using this medication
do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: yellowing
eyes/skin, stomach/abdominal pain, dark urine, unusual tiredness/weakness, easy
bleeding/bruising, signs of infection (such as fever, persistent sore throat), mental/mood
changes, unusual/sudden weight gain, seizures.

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not
consume enough calories from food or if you do unusually heavy exercise. Symptoms of low
blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision,
dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low
blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar
by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or
non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To
help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check
with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion,
drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell
your doctor immediately. Your medication dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if
you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling
(especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above,
contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side
effects to Health Canada at 1-866-234-2345.
PRECAUTIONS:
Before taking glimepiride, tell your doctor or pharmacist if you are allergic to it; or if you
have any other allergies. This product may contain inactive ingredients, which can cause
allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially
of: liver disease, kidney disease, thyroid disease, certain hormonal conditions
(adrenal/pituitary insufficiency, syndrome of inappropriate secretion of antidiuretic hormone-
SIADH), electrolyte imbalance (hyponatremia).

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high
blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or
clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing
low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever,
infection, injury, or surgery). Consult your doctor because this may require a change in your
treatment plan, medications, or blood sugar testing.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure,
tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist about all the products you use (including
prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially low blood
sugar.

During pregnancy, this medication should be used only when clearly needed. Discuss the
risks and benefits with your doctor.

Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your
blood sugar while pregnant. Your doctor may change your diabetes treatment during your
pregnancy (such as diet and medications including insulin).

It is unknown if this medication passes into breast milk. However, similar drugs pass into
breast milk. Breast-feeding while using this medication is not recommended. Consult your
doctor before breast-feeding.

DRUG INTERACTIONS:
See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious
side effects. This document does not contain all possible drug interactions. Keep a list of all
the products you use (including prescription/nonprescription drugs and herbal products) and
share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any
medicines without your doctor's approval.
Many drugs can affect your blood sugar levels, making it more difficult to control your blood
sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist
about how the medication may affect your blood sugar. Check your blood sugar levels
regularly as directed by your doctor. Tell your doctor about the results and of any symptoms
of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust
your anti-diabetic medication, exercise program, or diet.

Beta-blocker medications (including metoprolol, propranolol, glaucoma eye drops such as


timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood
sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as
dizziness, hunger, or sweating are unaffected by these drugs.

Check the labels on all your medicines (such as cough-and-cold products) because they may
contain ingredients that could affect your blood sugar. Ask your pharmacist about using those
products safely.

OVERDOSE:
If overdose is suspected, contact a poison control center or emergency room immediately. US
residents can call their local poison control center at 1-800-222-1222. Canada residents can
call a provincial poison control center. Symptoms of overdose may include: shakiness, fast
heartbeat, sweating, loss of consciousness.

NOTES:
Do not share this medication with others.

Attend a diabetes education program to learn more about diabetes and the important aspects
of its treatment, including medications, diet, exercise, and getting regular eye/foot/medical
exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check
your blood sugar levels regularly as directed.

Keep all regular medical and laboratory appointments. Laboratory and/or medical tests (such
as liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood
counts) should be performed periodically to monitor your progress or check for side effects.

MISSED DOSE:
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose,
skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch
up.

STORAGE:
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep
all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so.
Properly discard this product when it is expired or no longer needed. Consult your pharmacist
or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For
information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507
(Canada).

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

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